MAUDE Adverse Event Report: VIVE HEALTH VIVE HEALTH; All terrain Knee walker

Model Number	MOB1019
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a safety incident involving the all terrain knee walker.While in use, the brake system failed, causing the customer to fall.There is a damaged/broken brake component as well as visible facial injury sustained from the fall.
Additional Manufacturer Narrative
A thorough review of our historical safety data confirms that this is the first time an issue of this nature has been reported for this device, suggesting it is an isolated incident.Upon initial contact, the customer's primary request was for a full product replacement.Vive health has reached out to the customer to offer further support and gather more clinical details; however, the customer has not mentioned whether any medical intervention was required, nor have they provided sufficient information to complete a full technical evaluation.

• Brand Name: VIVE HEALTH
• Common Device Name: All terrain Knee walker
• Manufacturer (Section D): VIVE HEALTH; 8955 fontana del sol way; naples FL 34109
• MDR Report Key: 50141193
• Report Number: 50141193
• Device Sequence Number: 15790083
• Product Code: ITJ
• UDI-Device Identifier: 00818323022896
• UDI-Public: 00818323022896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 04/09/2026
• Report Date (Section F): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MOB1019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2026
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female